It is generally recognized that women at a certain age become afflicted with menopause and premenstrual symptoms which result in a variety of unpleasant problems, including vaginal dryness and pain. During menopause there is decrease in the hormone estrogen, or decrease in the hormone progesterone, a precursor to estrogen. Decreased estrogen levels can cause vaginal atrophy with the vaginal walls becoming drier and thinner. Women afflicted with these symptoms show less interest in sex due to pain during sexual intercourse, and at times exhibit slower arousal time. Such hormonal changes also disrupt the delicate acid-alkaline balance of the vagina which can lead to increased susceptibility to yeast and bacterial infections. U.S. Pat. No. 5,498,631 issued to Gorbach et al. on Mar. 12, 1996 discloses that symptoms of menopause can be treated by estrogen replacement therapy. However such treatment has been shown to increase the risk of certain cancers, such as endometrial cancer and breast cancer. As the aforementioned patent also discloses, changes in the level of endogenous estrogen may cause premenstrual syndrome in younger women. This condition is treated with a variety of non-hormonal therapies which can cause undesirable side effects. According to said patent, syndromes of menopause or premenstrual syndrome, or a condition which results from reduced levels of endogenous estrogen, may be prevented, or treated, by administering to the woman an effective amount of isoflavonoids, which are naturally occurring substances found primarily in soybeans. The isoflavonoids are administered by placing the patient on a diet containing high levels of soy-based foods such as, for example, tofu, miso, soybean or plant products rich in isoflavonoids.
Another patent, i.e., U.S. Pat. No. 5,612,061 issued to Simon W. Rabkin on Mar. 18, 1997 discloses a composition for the treatment of premenstrual syndrome comprising calcium, magnesium, acetaminophen and pamabrom, and a method of administering an effective amount of said composition to a patient in need of relief of premenstrual syndrome.
A more recent patent, i.e., U.S. Pat. No. 5,891,440 issued to Ephraim Philip Lansky on Apr. 6, 1999 discloses a phytoestrogen supplement which can be administered orally to relieve symptoms in menopausal women, or it can be administered topically as an ointment in order to relieve vaginal dryness and lack of skin tones. The ointment is prepared by pressing pomegranate seeds to obtain pomegranate seed oil, and mixing the seed oil with coconut milk to form the ointment. The ointment can also contain an ethanolic extract of Chinese asparagus root and shizandra berries.
Other investigators have addressed these uniquely female physiological problems and have developed oral medications which contain natural ingredients such as herbs and vitamins in order to provide relief from menopausal syndrome. However, none of the oral medications or other available medications has proven to be satisfactory for relieving vaginal dryness. Accordingly, there is a dire need for a composition, which can be conveniently applied to the vaginal area to provide the required relief from menopausal symptoms.
It is therefore an object of the present invention to provide a composition which is useful in providing a women with relief from vaginal dryness, premenstrual pain and menopausal symptoms.
It is another object of the present invention to provide such composition which contains certain combination of natural herbs for providing the required relief.
It is a further object of the present invention to provide said composition in gel form or a suppository which can be easily applied by the patient to the vaginal area in order to treat vaginal dryness, pain and other problems associated with menopause and premenstrual symptoms.
It is also an object of the present invention to provide a method of making said composition for topical application to the vaginal area.
The foregoing and other objects and features of the present invention will be more fully comprehended from the following detailed description, including clinical data obtained from topical application of the composition to women in need of relief from vaginal dryness and other menopausal problems.